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The feeder studies (i.e., IMVT-1401-3201 and 3202) for study IMVT-1401-3203 failed to achieve their pre-defined primary efficacy outcomes. Accordingly, there was a change to the benefit-risk balance. No new safety findings were observed.
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This is a 2-cohort (observational and treatment cohort) extension study for participants completing feeder studies (IMVT-1401-3201 or IMVT-1401-3202). The observational cohort will assess the durability of proptosis response of feeder studies off treatment. The treatment cohort will evaluate the efficacy of batoclimab as assessed by proptosis responder rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational cohort | Other | Proptosis responders in feeder studies will enter in a non-treatment observational study |
|
| Treatment Cohort | Experimental | Proptosis non-responders in feeder studies will be administered batoclimab of 680 milligram (mg) subcutaneous (SC) for 12 weeks followed by 340 mg SC for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational cohort study | Other | Observational cohort study |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of proptosis response off treatment in study eye in batoclimab responder participants in the feeder studies | Up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of proptosis responders in study eye in placebo non-responder participants in the feeder studies | At Week 24 | |
| Percentage of proptosis responders in study eye in batoclimab non-responder participants in the feeder studies | At Week 24 |
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Inclusion criteria:
For all participants:
1. Have completed the Week 24 visit of the feeder study.
For participants assigned to the Open-label Treatment Cohort:
Additional inclusion criteria are defined in the protocol.
Exclusion criteria:
For all participants:
1. In the Investigator's judgement, the benefits of entry in the study do not outweigh the risk.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Number - 1520 | Glendora | California | 91741 | United States | ||
| Site Number - 1501 |
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| Batoclimab |
| Drug |
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody |
|
|
| Aurora |
| Colorado |
| 80045 |
| United States |
| Site Number - 1526 | Livonia | Michigan | 48152 | United States |
| Site Number - 1513 | Rochester | Minnesota | 55905 | United States |
| Site Number - 1540 | Las Vegas | Nevada | 89184 | United States |
| Site Number - 1508 | Houston | Texas | 77030 | United States |
| Site Number - 1558 | Mesquite | Texas | 75149 | United States |
| Site Number - 1511 | Morgantown | West Virginia | 26506 | United States |
| Site Number - 1518 | Milwaukee | Wisconsin | 53226 | United States |
| Site Number - 7565 | Sydney | 2000 | Australia |
| Site Number - 4671 | Bruges | 8000 | Belgium |
| Site Number - 4672 | Brussels | 1070 | Belgium |
| Site Number - 4673 | Brussels | 1200 | Belgium |
| Site Number - 4670 | Ghent | B-9000 | Belgium |
| Site Number - 3454 | Tbilisi | 114 | Georgia |
| Site Number - 3455 | Tbilisi | 114 | Georgia |
| Site Number - 3450 | Tbilisi | 159 | Georgia |
| Site Number - 3451 | Tbilisi | 159 | Georgia |
| Site Number - 7550 | Budapest | 1133 | Hungary |
| Site Number - 7552 | Pécs | 7623 | Hungary |
| Site Number - 4760 | Ramat Gan | Tel Aviv | 5265601 | Israel |
| Site Number - 4764 | Afula | 1834111 | Israel |
| Site Number - 4761 | Jerusalem | 91120 | Israel |
| Site Number - 4762 | Petah Tikva | 4941492 | Israel |
| Site Number - 6207 | Catania | CAP95125 | Italy |
| Site Number - 6204 | Milan | 20122 | Italy |
| Site Number - 6203 | Milan | 20149 | Italy |
| Site Number - 6205 | Naples | 80131 | Italy |
| Site Number - 6209 | Palermo | 90127 | Italy |
| Site Number - 6201 | Pisa | 56124 | Italy |
| Site Number - 6202 | Rome | 00189 | Italy |
| Site Number - 9301 | Ogre | LV-5001 | Latvia |
| Site Number - 9300 | Riga | LV-1006 | Latvia |
| Site Number - 9302 | Ventspils | LV3601 | Latvia |
| Site Number - 7570 | Christchurch | 8013 | New Zealand |
| Site Number - 3107 | Gliwice | Silesian Voivodeship | 44-102 | Poland |
| Site Number - 3101 | Krakow | 30-688 | Poland |
| Site Number - 3104 | Lublin | 20-171 | Poland |
| Site Number - 3105 | Lublin | 60-354 | Poland |
| Site Number - 1990 | San Juan | 00921 | Puerto Rico |
| Site Number - 9200 | Bratislava | 82606 | Slovakia |
| Site Number - 9201 | Bratislava | Slovakia |
| Site Number - 9202 | Trenčín | 91101 | Slovakia |
| Site Number - 3602 | Barcelona | Catalonia | 8006 | Spain |
| Site Number - 3604 | Madrid | 28034 | Spain |
| Site Number - 3600 | Santiago de Compostela | 15706 | Spain |
| Site Number - 3606 | Seville | 41009 | Spain |
| Site Number - 3603 | Valencia | 46026 | Spain |
| Site Number - 7305 | Guildford | GU2 7XX | United Kingdom |
| Site Number - 7303 | London | EC1V 2PD | United Kingdom |
| Site Number - 7312 | London | W1T 6AH | United Kingdom |
| Site Number - 7313 | London | W1T 7HA | United Kingdom |
| Site Number - 7300 | Manchester | M139WL | United Kingdom |
| Site Number - 7302 | Newcastle upon Tyne | NE1 3BZ | United Kingdom |
| Site Number - 7308 | Sheffield | S102SB | United Kingdom |
| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D006111 | Graves Disease |
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D007154 | Immune System Diseases |
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